4076 CapSureFix Novus
Pacing
4076 CapSureFix Novus
VENTRICULAR PLACEMENT
Information

Device Survival Probability

4076_VEN_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr 10 yr 11 yr at 138.0 mo                  
% Survival 99.7 99.7 99.7 99.6 99.4 99.4 99.0 99.0 98.7 98.7 98.7 98.7                  
#   1326 1174 1044 885 685 550 433 341 219 142 97 64                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1602
Cumulative Months of Follow-Up 92375
Number of Leads Active in Study 442
Information 11

Qualifying Complications

Conductor Fracture 1
Extra Cardiac Stimulation 1
Failure to Capture 5
Impedance Out of Range 2
Lead Dislodgement 1
Other 1
ATRIAL PLACEMENT
Information

Device Survival Probability

4076_ATR_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr 10 yr 11 yr at 138.0 mo                  
% Survival 99.8 99.6 99.6 99.4 99.3 98.9 98.7 98.7 98.7 98.7 98.7 98.7                  
#   2970 2587 2242 1862 1426 983 709 489 285 162 95 51                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 3584
Cumulative Months of Follow-Up 185977
Number of Leads Active in Study 1480
Information 24

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 2
Failure to Capture 7
Failure to Sense 3
Insulation (not further defined) 2
Lead Dislodgement 7
Oversensing 1
Other 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 122
Conductor Fracture 6
Extra Cardiac Stimulation 17
Failure to Capture 159
Failure to Sense 63
Impedance Out of Range 26
Insulation Breach 1
Lead Dislodgement 429
Oversensing 48
Unspecified Clinical Failure 10
Information

Distribution Data

US Market Release2004-02-25
CE Approval Date2004-06-14
Registered USA Implants617699
Estimated Active USA Implants432695
US Market Release2004-02-25
CE Approval Date2004-06-14
Estimated WW Distribution1350790
Information

USA Returned Product Analysis

Conductor Fracture 93
Insulation Breach 132
Crimp/Weld/Bond 1
Other 20
Information

WW Returned Product Analysis

Conductor Fracture 109
Insulation Breach 138
Crimp/Weld/Bond 1
Other 27
Information

Product Characteristics

Lead Type Pacing
Type and/or Fixation Active Screw In
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Atrium or Right Ventricle
Pace/Sense Polarity Bipolar
More
Serial Number Prefix BBL
Lead Body Diameter 5.7 FR
Insulation Polyurethane/Silicone
Pace/Sense Connector Style IS-1 BI
High Voltage Connector n/a
Steroid Yes
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Data as of April 11, 2019

www.medtronic.com/productperformance 651050